(561 days)
- The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes the performance of "CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)" against established standards for patient examination gloves.
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D 3578-91) | Reported Device Performance (CHEMO PLUS Powder Free Blue Latex Examination Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| Size XS | - | - |
| Size S | min 230 | 292 |
| Size M | min 230 | 304 |
| Size L | min 230 | 308 |
| Size XL | - | - |
| 3. Palm width (mm) | ||
| Size XS | - | - |
| Size S | 80 ± 10 | 83 |
| Size M | 95 ± 10 | 95 |
| Size L | 111 ± 10 | 106 |
| Size XL | - | - |
| 4. Thickness (mm) | ||
| Finger | min 0.08 | 0.46 |
| Palm | min 0.08 | 0.27 |
| 5. Physical Properties: Before Ageing | ||
| Tensile Strength (MPa) | min 21 | 30.78 |
| Ultimate Elongation (%) | min 700 | 839 |
| 5. Physical Properties: After Ageing | ||
| Tensile Strength (MPa) | min 16 | 27.41 |
| Ultimate Elongation (%) | min 500 | 845 |
| 6. Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for watertightness, length, etc.). It generally refers to "performance test data."
The data provenance is from WEMBLEY RUBBER PRODUCTS (M) SDN BHD in Malaysia. The study is a non-clinical performance test of the manufactured device. It is a retrospective evaluation of the product's characteristics against a standard, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" (acceptance criteria) for most tests is the ASTM D 3578-91 standard itself. For the "Watertight (1000 ml)" test, the acceptance criteria is "S-4, AQL 4.0," which is a widely accepted standard in glove manufacturing. The protein content claim is a specific assertion about the glove's composition. These are objective measures against established technical standards, not subjective expert assessments.
4. Adjudication method for the test set
This information is not applicable as the tests are objective measurements against published standards (ASTM D 3578-91 and FDA 1000 ml watertight test). There is no reference to human experts adjudicating results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document describes the performance characteristics of medical examination gloves, not an AI or imaging device that would involve human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes the physical and chemical performance of medical examination gloves, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used primarily consists of established technical standards and specifications:
- ASTM D 3578-91: This is a comprehensive standard for rubber examination gloves.
- FDA 1000 ml watertight test: Another specific test for glove integrity.
- Protein content labeling claim: A manufacturer-defined specification for the protein level, which is then verified using a standard method (ASTM D5712).
These are objective, quantifiable criteria.
8. The sample size for the training set
This is not applicable. This is not a machine learning model, so there is no training set. The data presented is for the performance evaluation of a manufactured product.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a machine learning model. The "ground truth" for the device's performance evaluation is established by the aforementioned ASTM and FDA specifications.
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Image /page/0/Picture/1 description: The image shows a logo with the letters WRP in bold, black font. The letters are arranged horizontally, with the W on the left, R in the middle, and P on the right. The logo is enclosed in a black, rounded rectangular border. The logo appears to be a trademark or brand identifier.
972615
WEMBLEY RUBBER PRODUCTS (M) SDN BHD (No: 147817-V)
l.ot 1, Jalan 3, Kawasan Perusahaan Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, Malaysia nrketing / QA Tel: (603) 846-1486 / 1867 Fax: (603) 846-1485 / 1557 Operations Tel: (603) 846-1495 / 1496 Fax: (603) 846-1488 / 1608
CONTACT PERSON : MR. Y. W. CHOW
510 (K) SUMMARY
- Trade Name : CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
-
- Common Name : Examination Gloves
-
- Classification Name : Patient Examination Glove
4. Substantial Equivalence :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
5. Description of device :
Class I latex patient examination glove 80 LZC, powder free, protein content labeling, that meets all of the requirements of ASTM standard D3578-91.
6. Intended use of device :
The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the chemotherapy agents and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
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Image /page/0/Picture/17 description: The image shows a circular logo with the letter 'A' in the center. The words 'REGISTERED MANUFACTURER' are arranged around the circle. Below the logo, there is some text that is not clearly visible due to the image quality.
Image /page/0/Picture/18 description: The image is a black and white circular logo. The logo contains the words "REGISTERED FIRM" around the outside of the circle. Inside the circle is a downward-pointing triangle above a heart shape. Above the circle is a symbol that looks like a crown.
Image /page/0/Picture/19 description: The image shows a logo with the word "REGISTERED" in a white oval shape, placed on top of a black diamond shape. Below the diamond, there is text that reads "MS ISO 9002 : 1994". The logo appears to be a certification mark, possibly indicating compliance with the MS ISO 9002 standard from 1994.
Image /page/0/Picture/20 description: The image shows the CE marking, a symbol used to indicate conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The marking consists of the letters "CE" in a specific font and layout. Below the CE marking, the text "COUNCIL DIRECTIVE 93/42/EEC" is visible, indicating the specific directive related to medical devices.
EN 16001 (1002) AND EN 20001 (1007)
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7. Summary of Performance data :
:
92615
| TEST | ASTM D 3578-91 | CHEMO PLUS Powder FreeBlue Latex ExaminationGloves (Protein ContentLabeling) |
|---|---|---|
| 1. Watertight (1000 ml) | S-4, AQL 4.0 | Pass based on AQL of 1.5 |
| 2. Length (mm) | ||
| SizeXSSMLXL | -min 230min 230min 230- | -292304308- |
| 3. Palm width (mm) | ||
| SizeXSSMLXL | -$80 \pm 10$$95 \pm 10$$111 \pm 10$- | -8395106- |
| 4. Thickness (mm) | ||
| FingerPalm | min 0.08min 0.08 | 0.460.27 |
| 5. Physical Properties | ||
| Before Ageing : | ||
| Tensile Strength (MPa)Ultimate Elongation (%) | min 21min 700 | 30.78839 |
| After Ageing : | ||
| Tensile Strength (MPa)Ultimate Elongation (%) | min 16min 500 | 27.41845 |
| 6.Powder Content | - | below 2 mg / glove |
| 7. Moisture Content | - | max 0.8% / glove |
| 8. Protein Content | - | below 50 microgram / gram |
Performance data of gloves to ASTM D 3578-91 and FDA 1000 ml watertight test.
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8. Substantial Equivalence based on assessment of Non-Clinical performance data
The performance test data of device as shown above indicate that this glove meets requirements of ASTM D 3578-91.
Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D5712 is below 50 microgram / gram.
9. Conclusion
This glove exceed the ASTM D 3578 91 requirements, meet pinhole FDA requirements, and below 50 microgram / gram protein content labeling claim.
Date Summary Prepared : June 17, 1997
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Mr. Chow Yue Wah Vice President QA/RA Wembley Rubber Products (M) Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang, Selangor Darul Ehsan, MALAYSIA
K972615 Re : Chemo Plus Powder-Free Blue Latex Trade Name: Examination Gloves (Protein Labeling Claim 50 Micrograms or Less) Regulatory Class: I Product Code: LYY November 10, 1998 Dated: November 17, 1998 Received:
Dear Mr. Chow Yue Wah:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Chow Yue Wah
through 542 of the Act for devices under the Electronic chrough 342 or eno notrol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acinding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmama/n.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) : _ K972615
Device Name : CHEMO PLUS POWDER FREE BLUE LATEX EAMINATION GLOVES (PROTEIN CONTENT LABELING) 50 MICROGRAMS OR LESS
Indications For Use :
-
- The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Concurrence of CDRH, Office of Device Evaluation (ODE)
- The chemotherapy examination glove is a specialty medical glove which is a The onemedial device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and chemotherapy agents.
Prescription Use (Per 21 CFR 801.109)
:
Over-The-Counter Use OR
Qlin S. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infect 510(k) Number
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.